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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.
Approximately 200 patients will be included in the study and randomized to either condition.
The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavior therapy | Experimental |
| |
| Stress management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Behavioral | A 10-week treatment based on exposure to symptoms and related feelings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks before randomization |
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks after treatment completion (10 weeks after randomization) |
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks 6 months after treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| Use of health care resources and societal production loss because of illness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils Lindefors, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internetpsykatrienheten, M57, Psykiatri sydväst | Stockholm | 181 86 | Sweden |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Stress management | Behavioral | A 10-week stress management treatment including applied relaxation and dietary advice. |
|
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry |
| Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| Level of IBS-symptoms | IBS-Severity Scoring System | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| Anxiety related to gastrointestinal symptoms | Visceral Sensitivity Index | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| Level of daily stress | Perceived stress scale | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| Subjective relief of IBS-symptoms | One question: "In the past week, have you had adequate relief from IBS pain or discomfort?" | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion |
| D004066 | Digestive System Diseases |